VolitionRx Limited has announced that the Company's NuQ® blood test has accurately detected 95% (19 out of 20) of pancreatic cancers within a 4,800-subject cancer trial at Hvidovre Hospital, University of Copenhagen in Denmark.
Overall, the 4,800-patient retrospective study was conducted to detect colorectal cancer (CRC). However this patient cohort also included 166 patients who, although suspected for CRC, were found to have a different cancer. Of these 166 patients, 20 patients were diagnosed with pancreatic cancer.
Analysis of patients' blood samples demonstrated that a panel of two NuQ® assays and the classical cancer marker CEA (carcino-embryonic antigen) distinguished 95% of pancreatic cancer cases from healthy subjects at 84% specificity.
Pancreatic cancer is one of the most deadly and difficult to detect and diagnose cancers, as the signs and symptoms are similar to many other illnesses. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone, and the five-year survival rate for pancreatic cancer is currently just 7%1. Pancreatic cancer is projected to become the second leading cause of cancer-related death in the U.S. by 20302.
VolitionRx Chief Scientific Officer, Dr. Jake Micallef, commented, "Although this study was not designed specifically as a pancreatic cancer study and the NuQ® assays used were not tailored for pancreatic cancer detection, it is very encouraging that a NuQ® panel test nonetheless detected nearly all the pancreatic cancer cases in this patient set. This substantiates the highly encouraging results from our previous pancreatic cancer trial that were recently published in the journal Clinical Epigenetics" (see Non-invasive blood-based test shown to detect 92% of pancreatic cancer cases in samples from 59 individuals for further details of this trial).
"Existing screening tests for pancreatic cancer are far from ideal, and tend to be either very invasive, expensive or inaccurate. VolitionRx strongly believes that blood-based testing for pancreatic and other cancers is the best platform for screening patients. These results provide compelling evidence that VolitionRx has an accurate, cost-effective, non-invasive, blood-based solution for pancreatic cancer diagnosis," concluded Dr. Micallef.
VolitionRx Chief Executive Officer, Cameron Reynolds, added, "We now have confirmation of pancreatic cancer detection at a very high rate, in two completely different patient sets collected independently in different countries. Moreover, this second patient set is a large sample set. These very encouraging results provide significant confidence to move forward with a large, dedicated pancreatic cancer study. At this time, we believe pancreatic cancer has the highest likelihood of being the second cancer for which we bring a NuQ® panel test to market, following CRC. Pancreatic cancer is deadly and currently very difficult to diagnose early, and we hope to provide a solution to this high unmet medical need."
The pancreatic cancer results from the Danish study compare favorably with the recently published results from VolitionRx's trial with Lund University in Sweden, which demonstrated a detection rate of 92% (23 of 25) of cancer cases at 100% specificity using a panel of four NuQ® assays and the classical CA19-9 cancer biomarker. Full details were published in the journal Clinical Epigenetics: http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf.
Last month, VolitionRx announced interim CRC results from the 4,800-subject trial at Hvidovre Hospital, which indicated that its NuQ® blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers.
The NuQ® tests utilize the Company's proprietary Nucleosomics® technology platform, which identifies and measures circulating fragments of DNA, called nucleosomes, for the presence of epigenetic cancer signals within the blood. Full details of ongoing clinical trials can be found at http://www.volitionrx.com/technology/clinical-trials-collaborations.